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FDA 510(k) Application Details - K002595
Device Classification Name
Accessory, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K002595
Device Name
Accessory, Assisted Reproduction
Applicant
CRYO BIO SYSTEM
3722 AVE. SAUALITO
IRVINE, CA 92606 US
Other 510(k) Applications for this Company
Contact
GABRIELE LINGENOLELE
Other 510(k) Applications for this Contact
Regulation Number
884.6120
More FDA Info for this Regulation Number
Classification Product Code
MQG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/21/2000
Decision Date
11/17/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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